Tramadol Hydrochloride Tablets Recalled Due to Inadequate Blister Packaging Seal
The Harvard Drug Group recalls Tramadol Hydrochloride Tablets 50 mg nationwide due to inadequately sealed blister packaging. Affected lot M04343 (expiration 04/2024) may have compromised product integrity.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class II drug recall for a packaging defect with no reported illnesses, injuries, or contamination. The recall is precautionary and addresses a potential risk of product degradation rather than immediate documented harm. Per the rubric, precautionary recalls with no reported adverse events are classified as Moderate.
Plain-English summary
The Harvard Drug Group is recalling Tramadol Hydrochloride Tablets, USP 50 mg, 100-count unit-dose blister packages due to a packaging defect: inadequately sealed blister packaging.
The affected lot number is M04343 with an expiration date of 04/2024. A total of 3,876 cartons were distributed nationwide in the United States. The tablets were manufactured by Sun Pharmaceutical Industries Ltd. in India and distributed by Sun Pharmaceutical Industries, Inc. (Cranbury, NJ) and Major Pharmaceuticals (Livonia, MI).
An inadequately sealed blister package may compromise the integrity of the medication. Consumers who have received affected units should return them to their pharmacy or healthcare provider for a replacement or refund.
The recalled product
- Product
- Tramadol Hydrochloride Tablets, USP 50 mg, Unit Dose 100-Count Tablets Rx only, Manufactured by: Sun Pharmaceutical Industries Ltd. Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Distributed by: M
- Manufacturer
- The Harvard Drug Group
- Category
- Drug
- Hazard
- inadequate-seal
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: M04343
- Exp. 04/2024
Distribution
Distributed nationwide across the United States.
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