American Health Packaging Recalls Clarithromycin Tablets Due to CGMP Deviations
American Health Packaging recalls specific lots of Clarithromycin tablets USP 500mg due to current good manufacturing practice deviations. Check your lot numbers.
Lower-risk recall
CGMP Deviations: Firm did not adequately investigate customer complaints.
Contact the company
What happened, in plain English
American Health Packaging is recalling Clarithromycin tablets, USP 500mg because the firm did not adequately investigate customer complaints. This recall affects 3,572 cartons distributed nationwide. The specific lots involved have expiration dates ranging from July to November 2015. Read more at govinfonow.com/recall/44594-american-health-packaging-recalls-clarithromycin-tablets-usp-500mg-packaged-in.
Source Summary by GovInfoNow · govinfonow.com/recall/44594-american-health-packaging-recalls-clarithromycin-tablets-usp-500mg-packaged-in · Updated October 12, 2026 · FDA enforcement record: FDA #D-1224-2015
Cite this page
“American Health Packaging Recalls Clarithromycin Tablets Due to CGMP Deviations.” GovInfoNow, updated October 12, 2026. https://govinfonow.com/recall/44594-american-health-packaging-recalls-clarithromycin-tablets-usp-500mg-packaged-in. Based on FDA recall #D-1224-2015 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1224-2015%22&limit=1).
Why it’s dangerous
The hazard is a deviation from current good manufacturing practices (CGMP) because the firm failed to adequately investigate customer complaints. The record does not describe the nature of these complaints or any resulting health risks, injuries, or product defects.
Who’s affected
Consumers who purchased Clarithromycin tablets, USP 500mg packaged in 10-count blisters within 5 blister packs per carton. The record does not specify which patients are at higher risk or what specific complaints were made.
How to tell if you have this one
Check your medication for the brand American Health Packaging and the NDC numbers 68084-437-11 (blisters) and 68084-279-65 (cartons). Verify if your lot number is 132323, 132960, 133707A, or 133707B.
- Brand
American Health Packaging- Category
Drug
All 13 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Nationwide
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-1218-2015 | Amlodipine besylate tablets, USP 2.5mg, packaged in 10-count blisters (NDC 68084-498-11); 10 blister packs per carton (NDC 68084-498-01); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217.; Lot #: 131924, Exp 07/31/2015 | 1,896 cartons |
| D-1219-2015 | Amlodipine besylate tablets, USP 5mg, packaged in 10-count blisters (NDC 68084-505-11); 10 blister packs per carton (NDC 68084-505-01); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217.; Lot#: 131954, 131955, Exp 08/31/2015 | 20,855 cartons |
| D-1220-2015 | Amlodipine besylate tablets, USP 10 mg, packaged in 10-count blisters (NDC 68084-506-11); 10 blister packs per carton (NDC 68084-506-01); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217.; Lot#: 131953, Exp 07/31/2015 | 1,745 cartons |
| D-1221-2015 | Azithromycin tablets, USP 500mg, packaged in 10-count blisters (NDC 68084-279-11); 3 blister packs per carton (NDC 68084-279-21); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217.; Lot#: 134419A, Exp 12/31/2015; Lot#: 193441B, Exp 02/29/2016; Lot#: 133684B, Exp 09/30/2015. | 2,558 cartons |
| D-1222-2015 | Azithromycin tablets, USP 600mg, packaged in 10-count blisters (NDC 68084-464-11); 3 blister packs per carton (NDC 68084-464-21); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217.; Lot#: 134420, 142540, Exp 7/31/2015 | 838 cartons |
| D-1223-2015 | Azithromycin tablets, USP 250mg, packaged in 10-count blisters (NDC 68084-278-11); 10 blister packs per carton (NDC 68084-278-01); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217.; Lot#: 134392, Exp 06/30/2015 | 2,068 cartons |
| D-1224-2015 | Clarithromycin tablets, USP 500mg, packaged in 10-count blisters (NDC 68084-437-11); 5 blister packs per carton (NDC 68084-279-65); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217.; Lot#: 132323, Exp 07/31/2015; Lot#: 132960, Exp 09/30/2015; Lot#: 133707A, Exp 10/31/2015; Lot#: 133707B, Exp 11/30/2015. | 3,572 cartons |
| D-1225-2015 | Famotidine tablets, USP 20mg, packaged in 10-count blisters (NDC 68084-172-11); 10 blister packs per carton (NDC 68084-172-01); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217.; Lot#: 132146, Exp 06/30/2015; Lot#: 132147, 132963, Exp 08/31/2015; Lot#: 132964, Exp 10/31/2015; Lot#: 134319, Exp 12/31/2015; Lot#: 134320, Exp 01/31/2016. | 97,837 cartons |
| D-1226-2015 | Lisinopril tablets, USP 5mg packaged in 10-count blisters (NDC 68084-060-11); 10 blister packs per carton (NDC 68084-060-01); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217.; Lot#: 131928, Exp 09/30/2015 | 4,718 cartons |
| D-1227-2015 | Lisinopril tablets, USP 10mg packaged in 10-count blisters (NDC 68084-061-11); 10 blister packs per carton (NDC 68084-061-01); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217.; Lot#: 131933, Exp 07/31/2015 | 13,532 cartons |
| D-1228-2015 | Lisinopril tablets, USP 20mg packaged in 10-count blisters (NDC 68084-062-11); 10 blister packs per carton (NDC 68084-062-01); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217.; Lot#: 131934, Exp 09/30/2015 | 5,591 cartons |
| D-1229-2015 | Lisinopril tablets, USP 40mg packaged in 10-count blisters (NDC 68084-064-11); 10 blister packs per carton (NDC 68084-064-01); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217.; Lot#: 131935, Exp 08/31/2015 | 1,516 cartons |
| D-1230-2015 | Zonisamide capsules, USP 100mg packaged in 10-count blisters (NDC 68084-008-11); 5 blister packs per carton (NDC 68084-008-65); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217.; Lot#: 132383: Exp Date: 07/31/2015; Lot#: 132989 Exp Date: 10/31/2015; Lot#: 133694 Exp Date: 03/31/2016l Lot#: 134418A Exp Date: 07/31/2016 & Lot#: 134418B Exp Date: 07/31/2016. | 5,416 cartons |
What to do — step by step
Check Your Lot Numbers
Verify if your Clarithromycin tablets match the recalled lot numbers: 132323, 132960, 133707A, or 133707B.
Contact Your Pharmacist
Speak with your pharmacist or healthcare provider to determine if you have the recalled product and what steps to take next.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 21 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-1224-2015 (June 1, 2015) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1224-2015 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 12, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.