Unrated Drug recall · FDA · Published July 29, 2021

Teva Cyclobenzaprine Tablets Recall: Microbial Contamination Risk

Teva Pharmaceuticals USA recalls 7.5mg cyclobenzaprine tablets due to potential microbial contamination in an excipient batch. Affected products have NDC 70199-014-01 or 1408822A, expiring 08/2023. No specific remedy is stated in the recall notice.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0775-2021Drug Teva Pharmaceuticals USA ›

Recall notice

CGMP Deviations: Out of specification (OOS) test result for Total Aerobic Microbial Count (TAMC) and Total Yeast and Mold Count (TYMC) for an excipient batch of Dibasic Calcium Phosphate.

Take action

Contact the company

Recalling firmTeva Pharmaceuticals USA400 Interpace Pkwy · Parsippany, NJ 07054-1120

✎ GovInfoNow plain-language explainer

Teva Pharmaceuticals USA is recalling 7.5mg cyclobenzaprine tablets that may contain microbial contamination from an excipient batch. This could pose a health risk if the tablets are taken without proper testing. Read more at govinfonow.com/recall/36006-teva-cyclobenzaprine-tablets-recall-microbial-contamination-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/36006-teva-cyclobenzaprine-tablets-recall-microbial-contamination-risk · Updated August 18, 2026 · FDA enforcement record: FDA #D-0775-2021

Cite this page

“Teva Cyclobenzaprine Tablets Recall: Microbial Contamination Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/36006-teva-cyclobenzaprine-tablets-recall-microbial-contamination-risk. Based on FDA recall #D-0775-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0775-2021%22&limit=1).

The FDA announced on July 29, 2021, that Teva Pharmaceuticals USA voluntarily recalled Cyclobenzaprine Hydrochloride Tablets due to current good manufacturing practice deviations involving out-of-specification microbial counts in an excipient batch. The recall affects 4,587 bottles distributed nationwide.

How to tell if you have it

Brand: Teva Pharmaceuticals USA
Product: Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, Rx Only
Manufacturer: Actavis Laboratories FL, Inc.
NDC: 70199-014-01
Lot Code: 1408822A
Expiration Date: 08/2023

The hazard

The recall was initiated because of current good manufacturing practice deviations resulting from out-of-specification test results for Total Aerobic Microbial Count and Total Yeast and Mold Count for an excipient batch of Dibasic Calcium Phosphate.

Context

GovInfoNow's records show Teva Pharmaceuticals USA has 97 other recalls on record since Oct. 11, 2013. Other recent recalls include the Jan. 18, 2022, Doxylamine Succinate Tablets recall for failed dissolution risk and the Jan. 10, 2022, Tretinoin Capsules recall for failed dissolution testing. Additional similar product recalls involve Octreotide Acetate vials and kits announced on March 17, 2026, and April 24, 2026, citing sterility risks.

How to tell if you have this one

Check the product label for NDC 70199-014-01 or 1408822A, and the expiration date of 08/2023. The product is a prescription-only 7.5mg cyclobenzaprine tablet bottle.

Brand
Teva Pharmaceuticals USA
Category
Drug

FDA recall event · 3 products

All 3 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
Product was distributed nationwide.

Recall number	Product, codes & lots	Quantity
D-0774-2021	Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 0591-3330-01; 1408821A, exp. date 08/2023 (labeler - Teva)	9,655 bottles
D-0775-2021	Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314, NDC 70199-014-01; 1408822A, exp. date 08/2023 (labeler - Casper)	4,587 bottles
D-0776-2021	Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314, NDC 57237-266-01; 1408824A, exp. date 08/2023 (labeler - Rising)	4,992 bottles

Based on the official FDA remedy

What to do — step by step

Check Product Label
Look for NDC 70199-014-01 or 1408822A on the label and expiration date 08/2023.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Product was distributed 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 15 months after the firm started it.

Jul 29, 2021Firm started the recall
Aug 27, 2021FDA classified it Class II
Sep 8, 2021Published in FDA’s Enforcement Report
Nov 4, 2022FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/36006-teva-cyclobenzaprine-tablets-recall-microbial-contamination-risk">Teva Cyclobenzaprine Tablets Recall: Microbial Contamination Risk (GovInfoNow)</a>

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-0775-2021 (July 29, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0775-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.