Prescript Pharmaceuticals, Inc. recalls Acetaminophen 300 mg with Codeine Phosphate 30 mg tablets, USP, 20-count M-Pak containers, Rx Only. Mnfct for:
Prescript Pharmaceuticals recalls 20-count acetaminophen with codeine tablets due to incorrect storage temperature label. The product should be stored at 20°C to 25°C (68°F to 77°F), not 15°C to 30°C (59°F to 86°F).
Lower-risk recall
Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) which differs from the original manufacturer declaration of; Store at 20¿C to 25¿C (68¿F to 77¿F).
Contact the company & request your remedy
What happened, in plain English
Prescript Pharmaceuticals is recalling 20-count acetaminophen tablets with codeine due to a labeling error about the correct storage temperature. This could lead to improper storage conditions if users follow the incorrect label instructions. Read more at govinfonow.com/recall/40589-prescript-acetaminophen-with-codeine-tablets-recall-incorrect-storage-temperature-label.
Source Summary by GovInfoNow · govinfonow.com/recall/40589-prescript-acetaminophen-with-codeine-tablets-recall-incorrect-storage-temperature-label · Updated October 7, 2026 · FDA enforcement record: FDA #D-0806-2018
Cite this page
“Prescript Acetaminophen with Codeine Tablets Recall: Incorrect Storage Temperature Label.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/40589-prescript-acetaminophen-with-codeine-tablets-recall-incorrect-storage-temperature-label. Based on FDA recall #D-0806-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0806-2018%22&limit=1).
Why it’s dangerous
The product label incorrectly states the storage temperature as 15°C to 30°C (59°F to 86°F) instead of the correct 20°C to 25°C (68°F to 77°F). This labeling error could lead to improper storage conditions if users follow the incorrect instructions.
Who’s affected
People who have the 20-count acetaminophen with codeine tablets (NDC 13107-059-99) from the manufacturer. Those who store the product at temperatures outside the correct range may be at risk of improper storage.
How to tell if you have this one
Look for the 20-count M-Pak containers labeled 'Acetaminophen 300 mg with Codeine Phosphate 30 mg tablets, USP, Rx Only'. The product has NDC code 13107-059-99 and was manufactured with lot number 0130131, expiring August 31, 2020.
- Brand
Prescript Pharmaceuticals- Product
Acetaminophen 300 mg with Codeine Phosphate 30 mg tablets, USP, 20-count M-Pak containers, Rx Only. Mnfct for:- Category
Drug
All 5 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
California.
| Recall number | Product, codes & lots | Quantity | NDC |
|---|---|---|---|
| D-0805-2018 | Clindamycin 150 mg capsules, USP, 30-count M-Pak container. Mnfct by: Lannett Co. Inc., Philadelphia, PA. Mnfct for: Lannett Co. Inc., Philadelphia, PA. Pckgd by PreScript Pharm. Inc. Pleasanton, CA 94566. NC 00527-1382-01, Bar Code 0639-30-176; Lot # 0130126 | 50 30-count containers | — |
| D-0806-2018 | Acetaminophen 300 mg with Codeine Phosphate 30 mg tablets, USP, 20-count M-Pak containers, Rx Only. Mnfct for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. Mnfct by: Aurolife Pharma LLC, Dayton, NJ 08810. Pckgd by PreScript Pharm Inc. Pleasanton, CA 94566. NDC: 13107-059-99 Bar Code 0078-20-2033; Lot # 0130131, EXP 8/31/20 | 1 20-count containers | 13107-058-30, 13107-058-01, 13107-058-05, 13107-058-99, 13107-059-30, 13107-059-01, 13107-059-05, 13107-059-99, 13107-060-30, 13107-060-01, 13107-060-05, 13107-060-99 |
| D-0807-2018 | Chlorhexidine 0.12% liquid, 473 MILLITERS. Rx Only. Mnfct for: XTTRUM Laboratories, Chicago, IL 60609. Mnfct by: pharmaceutical Assoiates, Inc., Greenville, SC 29605. Distrib by: PreScript Pharm. INC., Pleasanton, CA 94588. NDC: 00116-2001-16, Bar Code 1385-38-482; Lot # 130128, EXP 08/31/20 | 24 473-ml bottles | — |
| D-0808-2018 | Clindamycin 300 mg capsules, USP, 28-count M-Pak containers, Rx Only. Mnfct for: Lannett Co. Inc., Philadelphia, PA 19136. Mnfct. by: Lannett Co. Inc., Philadelphia, PA 19136. Pckgd by PreScript Pharm. Inc., Pleasanton, CA 94566. NDC: 00527-1383-01, Bar Code 0784-28-11; Lot # 0130132, EXP 3/31/19 | 5 28-count containers | — |
| D-0809-2018 | Acetaminophen 300 mg with Codeine Phosphate 30 mg tablets, USP, 20-count M-Pak containers, Rx Only. Mnfct for: Mallinckrodt Inc. Hazelwood, MO 63042. Mnfct by:Mallinckrodt Inc. Hazelwood, MO 63042. Pckgd by PreScript Pharm Inc. Pleasanton, CA 94566 NDC: 00406-0484-10 Bar Code 0078-20-1834; Lot # 0130130 EXP 12/31/20 | 199 tablets in 20-count containers | — |
What to do — step by step
Check Storage Conditions
Ensure the product is stored between 20°C and 25°C (68°F to 77°F) if you have the product.
Questions people ask
Why is this product being recalled?
The product label incorrectly states the storage temperature as 15°C to 30°C (59°F to 86°F) instead of the correct 20°C to 25°C (68°F to 77°F).
What should I do if I have this product?
Check if the product is stored within the correct temperature range (20°C to 25°C or 68°F to 77°F). If not, contact your pharmacist or healthcare provider for advice.
Is there a remedy for this recall?
The recall record does not specify a remedy. You should check the storage conditions and contact your pharmacist or healthcare provider if needed.
Contact Prescript Pharmaceuticals
We’ve drafted a message you can send Prescript Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0806-2018 — Prescript Pharmaceuticals Acetaminophen 300 mg with Codeine Phosphate 30 mg tablets, USP, 20-count Hello, I own a Acetaminophen 300 mg with Codeine Phosphate 30 mg tablets, USP, 20-count M-Pak containers, Rx Only. Mnfct for: that is covered by recall D-0806-2018 from Prescript Pharmaceuticals. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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-0806-2018 (April 24, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0806-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 7, 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.